MS Drug Works in Kids

Fingolimod (Gilenya) cut the annualized relapse rate in the first-ever trial of a multiple sclerosis drug in a pediatric population compared with interferon beta-1a, drugmaker Novartis announced today.

According to top-line results from the phase III PARADIGMS trial, children and adolescents with MS randomized to the once-daily oral S1P modulator had a "significant and clinically meaningful reduction in the number of relapses ... over a period of up to two years," compared with interferon, the company stated.

In kids, the drug had a safety profile that was similar to that seen in adult trials, with more adverse events in the interferon group, according to the release.

The program enrolled 215 children and adolescents ages 10 to 17 years who were randomized to 0.5 mg or 0.25 mg of fingolimod depending on their weight, or to interferon. It was conducted at 87 sites in 25 countries, and was designed in partnership with the FDA, the EMA, and the International Pediatric Multiple Sclerosis Study Group. It also includes a five-year open-label extension phase.

Among the 2.3 million people around the world who have MS, 3% to 5% are estimated to be children, according to the release. The majority of these kids (98%) have relapsing-remitting MS.

Currently, there are no approved therapies for treating this population.

Full results from the trial will be presented at the upcoming ECTRIMS meeting in Paris.

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